Gestational Diabetes
Conditions
Keywords
gestational diabetes, oral glucose tolerance test, glucose sensor
Brief summary
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent & screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
Interventions
DEVICEDexcom glucose sensor
Use of a Dexcom G6 Pro
Sponsors
DexCom, Inc.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* include diagnosis of gestational diabetes during a current or recent pregnancy * age 18 or older.
Exclusion criteria
* include known pregestational diabetes, * known skin adhesive allergy which would prevent subject from wearing a CGM, * chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least 72 Hours of CGM Data Downloaded. | Postpartum days 10-20 | Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | up to 12 weeks postpartum | Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported. |
| Positive Predictive Value (PPV) | up to 12 weeks postpartum | PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. |
| Specificity | up to 12 weeks postpartum | Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported. |
| Negative Predictive Value (NPV) | up to 12 weeks postpartum | NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. |
| Negative Likelihood Ratio (NLR) | up to 12 weeks postpartum | NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. |
| Positive Likelihood Ratio (PLR) | up to 12 weeks postpartum | PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted from February 2023-January 2024 at a single urban medical center.
Participants by arm
| Arm | Count |
|---|---|
| Postpartum Glucose Sensor Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not complete routine postpartum OGTT | 9 |
| Overall Study | did not return second CGM sensor | 4 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | unblinding of sensor data | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Postpartum Glucose Sensor |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 5.7 |
| Delivery type C-section | 17 Participants |
| Delivery type Vaginal | 33 Participants |
| Education Level College degree | 16 Participants |
| Education Level High school/GED | 3 Participants |
| Education Level Post college | 14 Participants |
| Education Level Prefer not to answer | 2 Participants |
| Education Level Some college | 8 Participants |
| Education Level Some high school or less | 7 Participants |
| Family history of type 2 diabetes | 30 Participants |
| GDM management Diet/Lifestyle only | 23 Participants |
| GDM management Insulin | 23 Participants |
| GDM management Oral agents | 4 Participants |
| Gestational diabetes (GDM) in prior pregnancy | 13 Participants |
| Hypertensive complications | 11 Participants |
| Insurance type Commercial | 33 Participants |
| Insurance type Medicaid | 17 Participants |
| Multigravida | 39 Participants |
| Number of prenatal visits | 13.8 visits STANDARD_DEVIATION 4.6 |
| Pre-pregnancy body mass index | 26.6 kg/m^2 |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 12 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 20 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 30 |
| other Total, other adverse events | 0 / 43 | 0 / 30 |
| serious Total, serious adverse events | 0 / 43 | 0 / 30 |
Outcome results
Primary
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
Time frame: Postpartum days 10-20
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Glucose Sensor | Number of Participants With at Least 72 Hours of CGM Data Downloaded. | 43 Participants |
Secondary
Negative Likelihood Ratio (NLR)
NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Negative Likelihood Ratio (NLR) | 0 ratio |
| Second Sensor | Negative Likelihood Ratio (NLR) | 0.4 ratio |
Secondary
Negative Predictive Value (NPV)
NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Negative Predictive Value (NPV) | 100 percent |
| Second Sensor | Negative Predictive Value (NPV) | 90 percent |
Secondary
Positive Likelihood Ratio (PLR)
PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Positive Likelihood Ratio (PLR) | 4.5 ratio |
| Second Sensor | Positive Likelihood Ratio (PLR) | 3.83 ratio |
Secondary
Positive Predictive Value (PPV)
PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Positive Predictive Value (PPV) | 53.49 percent |
| Second Sensor | Positive Predictive Value (PPV) | 50 percent |
Secondary
Sensitivity
Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
Population: Results for usable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Sensitivity | 100 percent |
| Second Sensor | Sensitivity | 66.67 percent |
Secondary
Specificity
Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported.
Time frame: up to 12 weeks postpartum
Population: Results for usable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postpartum Glucose Sensor | Specificity | 78 percent |
| Second Sensor | Specificity | 83.33 percent |